From Push to Pull with EMA:

A Modern Take on Triaging Adverse Events

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In October 2017, the European Medicines Agency (EMA) changed the way in which they deliver safety information to Marketing Authorisation Holders. In the past, they would push the information via a gateway-to-gateway connection in an R2 format, which only delivered cases that were relevant to the receiver. In the new approach, the EMA is leveraging an E2B R3 format, and as opposed to pushing the cases in a gateway-to-gateway connection, it now requires Marketing Authorisation Holders to:

  1. Log in to a common portal
  2. Download cases using “Active Substance” as search key most of the times
  3. Identify cases from that day’s batch that are relevant to them
  4. Import the identified cases into their safety system

But, is there an easier way? Machine learning can be used to add efficiency and automate the search for relevant cases. This is done by matching customer specific criteria against the available product details within files available for download. Thus, significantly reducing the amount of manual effort and hours spent triaging downloaded files.

Learning Objectives:

  • Discuss the changes to safety information handling by the EMA
  • Address the impact of the changes to Marketing Authorisation Holders
  • Provide a practical solution to simplify and in some areas supplant the current manual processes
  • Demonstrate real use cases, based on product search criteria